Director - Product Development Quality Assurance (all genders) (permanent ­­/­­ full-time)

Make your mark: Establish, maintain, and execute quality systems to ensure disposition of clinical trial supplies, including API / drug substance, ingredients, bulk drug product and finished investigational products (pharmaceutical drug products as well as drug / device combination products), testing, and related documents Manages a quality organization of up to 5 direct reports and up to 50 total QA department members. Directly responsible for the effective organization, administration, training, and supervision of the Product Development Quality Organization Drive drug development project implementation via roles on the CMC Team or other cross-functional product subteams as needed to proactively avoid, manage, or address quality-related issues Collaborate cross-functionally (e.g., with Dev Sci, DevOps, Regulatory Affairs, Medical Safety, and Operations) to ensure early involvement of global key decision makers and prepare for aligned decision-making Ensure that GMP requirements are well understood in R&D development teams, facilitate education where required Ensure quality and safety of IMP. Ensure compliance of IMP: pharmaceutical drug and drug / device combination products with worldwide quality and regulatory requirements and IMPD / CTA applications Establish and regularly evaluate quality and key performance indicators, forwarding data for management reviews and communication to business partners Provide management oversight of review and approval of manufacturing and analytical batch records, exception reports, OOS reports, and changes in the quality system Responsible for Quality Management in pilot plants and labs Ensure that EU GMP requirements are appropriately addressed in collaboration processes (e.g. global product supply chain, QP role, execution of the Quality System) and in the respective Technical Quality Agreements (TQAs) Ensure suitable quality agreements or quality aspects of contracts for GMP-controlled activities are in place between R&D and third-party manufacturers, third-party labs, other service providers, customers, and other sites Support integration of acquisitions and perform GMP assessment of due diligences or in-licensing activities Develop a risk-based approach for decision-making and support continuous improvement via development of cost-efficient processes at sites, and collaboration between sites to optimize global processes and share best practices Advance local and global initiatives on continuous improvement and strategic initiatives in areas of responsibility